Bladder Tumors, Dexmedetomidine, Hemodynamic and Respiratory Monitoring, Magnesium Sulfate, Postoperative Pain, Spinal Anesthesia
Conditions
Keywords
postoperative analgesia, Integrated Pulmonary Index, TURBT
Brief summary
This randomized controlled trial evaluated the effects of intraoperative intravenous magnesium sulfate versus dexmedetomidine on postoperative pain, analgesic consumption, hemodynamic stability, and respiratory function in patients undergoing elective transurethral resection of bladder tumor (TUR-M) under spinal anesthesia. Magnesium sulfate significantly reduced postoperative pain scores, delayed the time to first analgesic request, and decreased total analgesic consumption compared to dexmedetomidine and control groups, while both agents were hemodynamically and respiratorily safe.
Detailed description
This study is a prospective, randomized, controlled trial designed to evaluate the effects of intraoperative intravenous magnesium sulfate versus dexmedetomidine infusions in patients undergoing elective transurethral resection of bladder tumor (TUR-M) under spinal anesthesia. Adult patients (age 18-85 years) with ASA physical status I-III scheduled for TUR-M were enrolled. Participants were randomly assigned to receive either magnesium sulfate, dexmedetomidine, or saline infusion during surgery. All patients received standardized spinal anesthesia. The study assesses postoperative pain, analgesic consumption, hemodynamic and respiratory parameters, and side effects. The trial aims to determine which agent provides better postoperative analgesia while maintaining cardiovascular and respiratory safety.
Interventions
DRUGmagnesium sulfate
Patients receive intravenous magnesium sulfate at 15 mg/kg/hour during TUR-M surgery under spinal anesthesia. The calculated dose is diluted in 50 mL of 0.9% sodium chloride and infused intravenously throughout the surgery. Postoperative analgesia is provided as rescue treatment based on VAS scores.
DRUGDexmedetomidine
Patients receive intravenous dexmedetomidine at 0.5 µg/kg/hour during TUR-M surgery under spinal anesthesia. The calculated dose is diluted in 50 mL of 0.9% sodium chloride and infused intravenously throughout the surgery. Postoperative analgesia is provided as rescue treatment based on VAS scores.
DRUGNormal Saline
Patients receive 15 mL/kg/hour of 0.9% sodium chloride without active pharmacological agents during TUR-M surgery under spinal anesthesia. Infusion is administered using the same protocol and devices as the experimental arms to maintain blinding. Postoperative analgesia is provided as rescue treatment based on VAS scores.
Sponsors
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is an interventional study with a parallel assignment model. Participants are randomly assigned to one of three groups (Magnesium Sulfate, Dexmedetomidine, or Control), and each group is observed independently and concurrently. The study is single-blind, meaning that the investigators and the statistician analyzing the data are unaware of the assigned infusion type, while participants do not know which group they are in. The primary purpose of the study is treatment, aiming to evaluate the intraoperative effects of magnesium sulfate and dexmedetomidine on postoperative analgesia, hemodynamic stability, and respiratory function.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Age between 18 and 85 years. Classified as ASA physical status I, II, or III according to the American Society of Anesthesiologists. Patients scheduled for elective transurethral resection of bladder tumor (TUR-M) under spinal anesthesia.
Exclusion criteria
Patients under 18 years or over 85 years of age. Contraindications to spinal anesthesia (e.g., infection at puncture site, coagulopathy). History or current diagnosis of significant cardiac arrhythmia. Known allergy or contraindication to the study drugs (magnesium sulfate or dexmedetomidine). Patients requiring conversion to general anesthesia due to inadequate spinal anesthesia intraoperatively. Mental retardation, cognitive impairment, or communication difficulties that prevent understanding of study procedures or pain assessment. Patients who refuse to participate in the study. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Analgesic Request | Postoperative period up to 24 hours | Time (in minutes) from the end of surgery until the patient first requests postoperative analgesia. |
| Total Postoperative Analgesic Consumption | 24 hours postoperative | Total amount of analgesics (paracetamol and tramadol) administered within 24 hours after surgery. |
| Postoperative Pain Scores | 24 hours postoperative | Pain intensity measured using the Visual Analog Scale (VAS) at the end of surgery, 60 minutes, 6 hours, and 24 hours after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Integrated Pulmonary Index (IPI) | During surgery | Respiratory effort and ventilatory adequacy measured intraoperatively. |
| Intraoperative heart rate | During surgery | Heart rate will be continuously monitored intraoperatively using standard anesthesia monitoring. Mean intraoperative heart rate will be recorded and reported in beats per minute (bpm). |
| Intraoperative systolic blood pressure | During surgery | Systolic blood pressure will be continuously monitored intraoperatively using standard anesthesia monitoring. Mean intraoperative systolic blood pressure will be recorded and reported in millimeters of mercury (mmHg). |
| Intraoperative diastolic blood pressure | During surgery | Diastolic blood pressure will be continuously monitored intraoperatively using standard anesthesia monitoring. Mean intraoperative diastolic blood pressure will be recorded and reported in millimeters of mercury (mmHg). |
| Intraoperative mean arterial pressure | During surgery | Mean arterial pressure will be continuously monitored intraoperatively using standard anesthesia monitoring. Mean intraoperative MAP values will be recorded and reported in millimeters of mercury (mmHg). |
| Adverse Effects | Intraoperative and 24 hours postoperative | Incidence of hypotension, bradycardia, desaturation, postoperative nausea and vomiting, and other side effects. |
Countries
Turkey (Türkiye)
Outcome results
None listed